BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOW CORNING SILASTIC MSI MAMMARY IMPLANT

    MDR report key: 2142460 · Received June 22, 2011

    Report

    Report Number
    MW5021117
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    July 21, 2008
    Report Date
    June 22, 2011
    Manufacturer
    DOW CORNING WRIGHT
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I REQUIRED SURGERY DUE TO RUPTURED DOW CORNING TEXTURED 350 CC BREAST IMPLANT. UPON REMOVAL, IT WAS DISCOVERED ONE IMPLANT HAD A FRANK RUPTURE AND THE OTHER HAD LOST APPROXIMATELY 1/2 CUP OF SILICONE DUE TO GEL BLEED. THERE WAS ALSO SIGNIFICANT SCAR TISSUE ATTACHED TO THE RIGHT BREAST, RUNNING UNDER MY ARMPIT. IT WAS DESCRIBED AS HAVING A "TAIL-LIKE" APPEARANCE, AND HAD BEEN CAUSING ME SIGNIFICANT DISCOMFORT AND PAIN PRIOR TO MY EXPLANT. THE ODDEST THING IS THAT I HAD DEVELOPED PRETTY SEVERE YEAR-ROUND ALLERGIES AND ASTHMA WITHIN THREE MONTHS OF GETTING THE IMPLANTS PUT IN. BOTH CONDITIONS RESOLVED WITHIN 6 MONTHS OF HAVING THEM OUT, AND I HAVE NOT BEEN ILL FROM EITHER SINCE THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOW CORNING SILASTIC MSI MAMMARY IMPLANT BREAST IMPLANTS FTR DOW CORNING WRIGHT SILASTIC MSI M607930
    2 DOW CORNING SILASTIC MSI MAMMARY IMPLANT BREAST IMPLANTS FTR DOW CORNING WRIGHT SILASTIC MSI M618670

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| S